CQV Engineer

Staffhub Group; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A leading staffing agency in Singapore is seeking a qualified professional to lead Commissioning, Qualification & Validation (CQV) activities for pharmaceutical projects. The ideal candidate will have a degree in Engineering or a related field, with a minimum of 5 years' experience in commissioning and qualification within pharmaceutical facilities. Responsibilities include overseeing field work, reviewing project documentation, and coordinating with contractors to ensure compliance with GMP standards.

Qualifications

• Minimum 5 years of relevant experience in commissioning and qualification activities for construction projects in pharmaceutical facilities.
• Thorough knowledge of pharmaceutical guidelines such as GMP, GDP, ASTM, FDA, ICH, ISPE.

Responsibilities

• Lead Commissioning, Qualification & Validation activities.
• Write and review project design documents and protocols.
• Coordinate with vendors and contractors.

Skills

Commissioning

Qualification

Validation

Risk analysis

Education

Degree in Engineering/Science related discipline

Job description

All jobs listed are based in Singapore only. For Singaporean only.

Responsibilities

• Lead Commissioning, Qualification & Validation (CQV) activities
• Lead a team and execute all field work such as Commissioning, Installation & Operational Qualification (IQ/OQ), Validation for downstream process equipment, CIP & Clean utilities to complete assigned tasks on time, on budget and safely while adhering to quality and engineering standards.
• Write and review project design documents (P&IDs, PFDs, URS, data sheets etc.), GMP/GDP documents and technical specifications, protocols preparation, execution and follow-up.
• Review and follow up the technical documentation from the early design phase in order to align it with GMP and C&Q requirements
• Preparation and review of FAT, Commissioning and SAT protocols.
• Support the preparation of the final reports to the end-user
• Perform risk analysis and review performance progress.
• Coordinate with vendor & contractors to achieve streamlined CQV.
• Perform other related duties as assigned by management

Qualifications

• Degree in Engineering/Science related discipline.
• Minimum 5 years’ relevant experience in commissioning and qualification activities for construction projects in pharmaceutical facilities.
• Thorough knowledge of pharmaceutical guidelines e.g. GMP, GDP, ASTM E2500-07, FDA, ICH, ISPE and CQV practices.
• Candidates with senior experiences will be considered for a senior role.